Validation of a Questionnaire to Identify Signs and Symptoms of Nephrogenic Systemic Fibrosis
1 other identifier
observational
60
1 country
1
Brief Summary
The Primary Aim of this study is to validate a questionnaire as a screening tool to identify subjects with symptoms suggestive of nephrogenic systemic fibrosis (NSF). The investigators believe that there will be difference between subjects with NSF and other skin conditions and normal skin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 17, 2009
CompletedFirst Posted
Study publicly available on registry
March 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedDecember 15, 2010
December 1, 2010
1.5 years
March 17, 2009
December 14, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in the number of "yes" answers between NSF subjects and subjects with non-fibrosing skin diseases or without skin diseases.
1 day
Secondary Outcomes (2)
Similarity in answers between NSF subjects and subjects with other fibrosing skin diseases.
1 day
Sensitivity of the questionnaire when applied to NSF subjects.
1 day
Study Arms (4)
1
subjects with a histologically-proven diagnosis of NSF
2
subjects with other fibrosing skin diseases
3
subjects with non-fibrosing skin diseases
4
subjects without skin diseases
Eligibility Criteria
Massachusetts General Hospital Dermatology and Rheumatology clinics
You may qualify if:
- Male or female subjects 18 years of age or older.
- Willing and able to understand and provide oral informed consent.
- Able to complete study and comply with study procedures.
You may not qualify if:
- Subject is unable to provide oral consent.
- Psychiatric or other conditions which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (3)
Todd DJ, Kay J. Nephrogenic systemic fibrosis: an epidemic of gadolinium toxicity. Curr Rheumatol Rep. 2008 Jul;10(3):195-204. doi: 10.1007/s11926-008-0033-6.
PMID: 18638427BACKGROUNDTodd DJ, Kagan A, Chibnik LB, Kay J. Cutaneous changes of nephrogenic systemic fibrosis: predictor of early mortality and association with gadolinium exposure. Arthritis Rheum. 2007 Oct;56(10):3433-41. doi: 10.1002/art.22925.
PMID: 17907148BACKGROUNDLima XT, Alora-Palli MB, Kimball AB, Kay J. Validation of a screening instrument for nephrogenic systemic fibrosis. Arthritis Care Res (Hoboken). 2013 Apr;65(4):637-42. doi: 10.1002/acr.21877.
PMID: 23097320DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Kay, MD
Massachusetts General Hospital
Study Design
- Study Type
- observational
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 17, 2009
First Posted
March 26, 2009
Study Start
March 1, 2009
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
December 15, 2010
Record last verified: 2010-12